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510(k) Data Aggregation
(136 days)
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
The subject device is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader. CELERITY Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the CELERITY 20 HP Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| BI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles | All BIs processed in half cycle will be negative for growth. | PASS |
| BI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles | All BIs inoculated with low numbers of Geobacillus stearothermophilus spores will demonstrate growth. | PASS |
| BI Simulated Use in the STERRAD Sterilizer Cycles | All BIs processed in full cycles will be negative for growth. | PASS |
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | PASS |
| Resistance (D-value) | D-value > 3 sec (at 9.1 mg/L H₂O₂) | PASS |
| Survival Time | Survival Time ≥ 4 sec (at 9.1 mg/L H₂O₂) | PASS |
| Kill Time | Kill Time ≤ 6 min (at 9.1 mg/L H₂O₂) | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use (V-PRO Sterilizers) | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of BIs per sterilization cycle for half-cycle, growth inhibition, or simulated use tests). It mentions "All BIs" in the acceptance criteria, suggesting a comprehensive evaluation.
The data provenance is from non-clinical testing performed by STERIS Corporation, a manufacturer in the United States (Mentor, Ohio). The studies are prospective as they are conducted to demonstrate the performance of the device for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. Biological Indicators (BIs) rely on the growth or non-growth of a reference microorganism (Geobacillus stearothermophilus) under controlled conditions to determine sterilization effectiveness. The "ground truth" is established through microbiological principles (presence/absence of live spores and enzyme activity) rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
This is not applicable as the results are based on objective biological and chemical reactions (fluorescence, growth/no growth), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices where human readers interpret outputs, often with and without AI assistance. This device is a biological indicator for sterilization monitoring, and its performance is evaluated directly through biological and chemical tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance evaluation is standalone (algorithm only) in the sense that the device's mechanism (fluorescence detection by the Celerity HP Incubator) operates automatically without human intervention once the BI is placed in the incubator. The results (fluorescent within 20 minutes for growth, or lack thereof) are objective outputs of the system. Human involvement is limited to placing the BI in the incubator and observing the incubator's output indicator.
7. The Type of Ground Truth Used
The ground truth is based on microbiological principles and direct observation of microbial growth or enzyme activity. Specifically:
- For sterilization efficacy, the ground truth is the absence of viable Geobacillus stearothermophilus spores after processing.
- For growth promotion/inhibition, the ground truth is the presence of viable Geobacillus stearothermophilus spores and their ability to grow, or the enzyme reaction leading to fluorescence.
- Reduced Incubation Time (RIT) Testing compared the 20-minute fluorescent results to the conventional 7-day incubation time results (which would involve visual inspection for growth over a longer period).
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this biological indicator. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its performance is based on established biological and chemical reactions and engineering controls.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this device, this question is not applicable.
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(91 days)
The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert VH2O2 Self-Contained Biological Indicator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The provided text describes the acceptance criteria and the summary of non-clinical tests for the "VERIFY Assert VH2O2 Self-Contained Biological Indicator". However, it's important to note that this document is for a biological indicator used in sterilization processes, not an AI/ML powered medical device for diagnostic purposes. As such, some of the requested information (like MRMC study, human reader improvement with AI, ground truth for training AI, etc.) is not applicable to this type of device.
Here's the information extracted and adapted where possible:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | PASS |
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time ≥ 4 sec | PASS |
| Kill Time | Kill Time ≤ 6 min | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample size used for the test set and the data provenance:
The document summarizes "non-clinical tests" but does not explicitly state the specific sample sizes for each test in the acceptance criteria table. It refers to "testing in accordance with FDA guidance for BI 510(k)" and "ISO 11138–1 media testing," which would imply standardized testing protocols that define sample sizes. Without further details of these specific tests, the exact sample sizes cannot be determined from the provided text.
The data provenance is not specified in terms of country of origin or explicit retrospective/prospective design. However, the tests are laboratory-based and conducted by the manufacturer, STERIS Corporation, in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to a biological indicator. The "ground truth" for a biological indicator is determined by the survival or inactivation of Geobacillus stearothermophilus spores under specific sterilization conditions, which is a microbiological and chemical measurement, not an expert human interpretation.
4. Adjudication method for the test set:
Not applicable, as the evaluation is based on objective microbiological and chemical results, not expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a biological indicator for sterilization, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "self-contained biological indicator" that produces a fluorescent result, which is then detected by an "automated incubator/reader." In this sense, the "algorithm" equivalent is the biological and chemical reaction within the indicator, and its detection by the automated reader. The performance described in the acceptance criteria is essentially its standalone performance in various conditions. There's no "human-in-the-loop" for the primary result generation, only for interpreting the automated reader's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for testing this biological indicator is based on:
- Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Chemical/Biological reactions: The enzyme reaction with a fluorogenic substrate to produce a fluorescent moiety, detected by the incubator.
- Standardized testing methods: Adherence to FDA guidance for BI 510(k) and ISO 11138–1 standards, which define the expected biological and chemical responses under controlled conditions (e.g., D-value, survival time, kill time).
8. The sample size for the training set:
Not applicable in the context of an AI/ML training set. This is a physical device, and its "performance" is inherent to its design and manufacture, validated through a series of non-clinical tests.
9. How the ground truth for the training set was established:
Not applicable in the context of an AI/ML training set. The "ground truth" for the device's development (if one were to call it that) would come from established principles of microbiology and sterilization science, as well as the performance characteristics of its constituent materials and biological components.
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(108 days)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
The provided text describes the regulatory filing (510(k) submission K171003) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H. This document details the non-clinical performance evaluation of a device designed to monitor sterilization processes, not an AI/ML medical device for diagnosis or prognosis involving human expert review of medical images.
Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "training set details," are not applicable to this specific device and the provided documentation. The study described is a laboratory performance test of a biological indicator and an auto-reader, not a study evaluating human reader performance with or without AI assistance on medical images.
However, I can extract the relevant information from the document to answer the applicable parts of your request:
Device and Study Overview
The device under review is the 3M™ Attest™ Rapid Readout Biological Indicator 1295, used in conjunction with the 3M™ Attest™ Auto-reader 490H. This submission addresses a software change to the Auto-reader to reduce the final fluorescent readout time from 4 hours to 24 minutes. The biological indicator itself (1295 BI) has the same design, materials, and fundamental scientific technology as the previously cleared device.
The "study" in this context refers to non-clinical performance testing conducted to demonstrate that the device, with the reduced readout time, still functions effectively as a biological indicator for monitoring vaporized hydrogen peroxide sterilization processes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Passed" results for each test. The actual quantitative acceptance thresholds are not explicitly listed in this summary, but the results confirm they were met.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Positive Control | Biological indicator shows growth/fluorescence. | Passed |
| Survival Time ≤ 5 seconds | Biological indicator shows growth/fluorescence. | Passed (Survival Time = 5 seconds) |
| Kill Time ≥ 7 minutes | Biological indicator shows no growth/fluorescence. | Passed (Kill Time = 7 minutes) |
| Reduced Incubation Time: Alignment with 7-day conventional incubation time | > 97% alignment | Passed (Meets FDA's requirements for Reduced Incubation Time with > 97% alignment) |
| Final fluorescent readout time | 24 minutes | 24 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of biological indicators tested for each performance criterion (e.g., how many BIs were used to determine survival time or kill time, or for the reduced incubation time study). It only states "No clinical data was included in this premarket application submission," indicating the tests were non-clinical.
- Data Provenance: The tests would have been conducted in a laboratory setting by 3M Company. The document does not specify the country of origin of the data, but 3M's contact address is St. Paul, Minnesota, USA. The studies are prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate the performance with the new readout time.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a non-clinical, in-vitro performance study of a biological indicator and auto-reader. Ground truth is established by the known conditions of the sterilization cycles (e.g., exposure time to sterilant) and the inherent biological response of the Geobacillus stearothermophilus spores. The "truth" is the presence or absence of viable spores after treatment, which is determined by the biological indicator's function, not by human expert interpretation of an outcome.
4. Adjudication Method for the Test Set
- Not Applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The device's readout (fluorescence) is an objective, automated measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is a non-clinical performance study of a device, not a study evaluating human reader performance (with or without AI assistance).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in essence. The testing described is a standalone performance evaluation of the integrated system (biological indicator + auto-reader algorithm) without human intervention in the interpretation of the results. The 490H Auto-reader automatically interprets the biological indicator and provides a fluorescent readout. The "algorithm" here is the system's ability to detect fluorescence within a specific incubation time.
7. The Type of Ground Truth Used
- Biological/Chemical Performance & Controlled Environmental Conditions: The ground truth for the "Passed" results is based on established scientific principles for biological indicators:
- Viable spores (positive control): Known viability and growth in ideal conditions.
- Survival Time: Exposure to a specific, short duration of sterilant where spores are expected to survive.
- Kill Time: Exposure to a specific, longer duration of sterilant where all spores are expected to be killed.
- Reduced Incubation Time Alignment: Comparison to the conventional, well-established 7-day incubation method, serving as a gold standard for biological indicator performance. The fluorescence indicates the presence (or absence) of enzyme activity from viable spores.
8. The Sample Size for the Training Set
- Not Applicable. This device does not use machine learning or AI models that require "training sets" in the conventional sense. The "training" of the device is its design and manufacturing to function according to biophysical principles, not an iterative data-driven process.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8). The device's function is based on the biological activity of bacterial spores and their response to sterilization, which is a well-understood and established scientific principle in microbiology and sterilization.
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